Philips Healthcare (Suzhou) Co., Ltd. June 17, 2021 ℅ Shiguang An Advanced Regulatory Engineer No. 258, Zhong Yuan Road, Suzhou Industrial Park Suzhou, Jiangsu 215024 CHINA

Re: K203514 Trade/Device Name: Precise Position Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: May 19, 2021 Received: May 19, 2021

Dear Shiguang An:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for

U.S. Food & Drug Administration 10903 New Hampshire Avenue Doc ID# 04017.04.26 Silver Spring, MD 20993 www.fda.gov K203514 - Shiguang An Page 2 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting- combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531- 542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting- mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical- devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Food and Drug Administration Expiration Date: 06/30/2023 Indications for Use See PRA Statement below.

510(k) Number (if known) K203514

Device Name

Precise Position

Indications for Use (Describe)

The Precise Position is intended for use with Philips Incisive CT systems. The device provides the following guided workflow.

• Patient orientation identification • Surview range recommendation • Automatic centering the patient anatomy • Provide visual images of patient on the table

Precise position is indicated for use for CT imaging of the head, chest, abdomen, pelvis, and combination of those anatomies.

Patient population limitation: Patient younger than 16 years are not supported.

Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [email protected] “An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.”

FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

Traditional 510(k)

510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.

Date Prepared: November 18, 2020 Manufacturer: Philips Healthcare (Suzhou) Co., Ltd. No. 258, ZhongYuan Road, Suzhou Industrial Park, 215024 Suzhou, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA Establishment Registration Number: 3009529630 Primary Contact Shiguang An Person: Advanced Regulatory Engineer Phone: +86-13940106467 E-mail: [email protected]

Secondary Contact Erhong Wang Person: Senior Regulatory Affairs Manager Phone: +86-13021019589 E-mail: [email protected]

Device Name: Precise position Classification: Classification Name Computed tomography x-ray system Classification Regulation: 21CFR §892.1750 Classification Panel: Radiology Device Class: Class II Primary product code: JAK

Predicate Device: Trade Name: Philips Incisive CT Manufacturer: Philips Healthcare (Suzhou) Co., Ltd. 510(k) Clearance: K180015-March 20, 2018 Classification Regulation: 21 CFR, Part 892.1750 Classification Name: Computed tomography x-ray system Classification Panel: Radiology Device Class: Class II Product Code JAK

Reference Device: Manufacturer: Auto Positioning

Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd. Section 5 - 510(k) Summary Precise Position Page 1 of 6

Traditional 510(k)

GE Hangwei Medical System Co., Ltd. 510(k) Clearance: K192956 (January 16, 2020) Classification Regulation: 21 CFR, Part 892.1750 Classification Name: Computed tomography x-ray system Classification Panel: Radiology Device Class: Class II Product Code JAK

Device Precise Position is an optional feature to assist user for position the description: patient before the body examination such as CT scan. The purpose of this feature is to reduce the patient position time via the camera detection and calculation result. It includes automatic detect patient orientation, patient anatomy scan range and center of patient anatomy.

Precise Position including a camera with both color and depth function is installed in the ceiling of the scan room, in such a way to cover the entire patient on the patient table. The camera control and image data transmit via the high speed fiber and copper hybrid USB cable. The power supply of the camera is from the gantry. Precise position adopts the AI algorithm (Convolution Neural Network) to detect the joints of the patient body, and then identify surview start/end position and patient orientation. The algorithm can also support detect center of patient anatomy.

Limitation for Precise Position There is no limitation for Precise Position except below items: • Patients below the age of 16 are not supported. • Decubitus orientations are not supported.

The Precise Position display results may get affected by the following conditions: • When the patient is covered by sheet, blanket etc., • When the patient is not completely covered by the ceiling camera view, e.g. blocked by the gantry or out of camera's FOV etc. • When the patient is wearing clothes that reflects light, e.g. plastic- like clothes. • When the patient is wearing black clothes. • When the patient is wearing thick clothes. • When there are other people around the patient.

Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd. Section 5 - 510(k) Summary Precise Position Page 2 of 6

Traditional 510(k)

Indications for The Precise Position is intended for use with Philips Incisive CT Use: systems. The device provides the following guided workflow.

• Patient orientation identification • Surview range recommendation • Automatic centering the patient anatomy • Provide visual images of patient on the table

Precise position is indicated for use for CT imaging of the head, chest, abdomen, pelvis, and combination of those anatomies.

Patient population limitation: Patient younger than 16 years are not supported.

Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd. Section 5 - 510(k) Summary Precise Position Page 3 of 6

Traditional 510(k)

Fundamental Based on the information provided above, the precise position is scientific considered substantially equivalent to the primary currently technology: marketed and predicate device Philips Incisive CT (K180015, 20/March/2018) in terms of fundamental scientific technology.

Attribute Predicate Device Proposed Device Precise Philips Incisive CT Position (K180015) Patient Manually position Precise position provides positioning the patient via the the auto workflow to set workflow couch motion button the surview start/end and laser. Normally, position, center of patient need several round anatomy, and patient adjustments by user. orientation. Detection The manual Precise position adopt the algorithm workflow does not AI algorithm (Convolution need special Neural Network) to detect algorithm. the joints of the patient

body automatically, and

then automatic detect

surview start/end position, center of patient anatomy and patient orientation. Hardware Manual patient Precision position feature need to positioning does not need color and depth support the need any unique camera, high speed USB patient hardware except transmission cable, and positioning traditional exiting power cable, and relative hardware on the CT the enhanced workflow. or other system. The tradition exiting Exiting hardware patient positioning includes table hardware still be available motion button for user all the time, it is (in/out, up/down) on convenient to switch gantry panel or between the camera CTBOX, lasers and automatically detecting etc. mode and manual mode. Patient All ages More than 16 years old. population Environment Hospitals, outpatient Hospitals, outpatient of use clinics, research clinics, research institutions, and institutions, and other other clinical clinical facilities.

facilities. Summary of Non- The Precise Position complies with the following international and Clinical FDA-recognized consensus standards:

Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd. Section 5 - 510(k) Summary Precise Position Page 4 of 6

Traditional 510(k)

Performance data: • AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012

(Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements. For Basic Safety and Essential Performance (IEC 60601-1:2012, MOD). FDA/CDRH recognition number 19-4 • IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance -– Collateral standard: Electromagnetic disturbances - Requirements and tests.

FDA/CDRH recognition number 19-8 • ISO 14971 Medical devices – Application of risk management to medical devices. FDA/CDRH recognition number 5-40. • IEC 62304:2015, Medical device software -- Software life cycle processes

FDA/CDRH recognition number 13-79 There are no risks identified in risk management documentation that require clinical data for the purpose of clinical evaluation; Risk Management Plan as Appendix 001, Risk Management Report as Appendix 002, and Risk Management Matrix as Appendix 003 of Precise Position. There are no clinical risks identified by the evaluated clinical data. Sufficient evidence is available to demonstrate the ability of Precise Position achieve the intended performances during normal condition of use. Full consistency exists between the state-of-the-art, the evaluated data, the risk management documentation and the information materials supplied. Therefore, the Precise Position is substantially equivalent to the primary currently marketed and predicate device (K180015, 20/March/2018) in terms of safety and effectiveness. Summary of Precise Position is evaluation covered total 80 clinical scan positions Clinical Data: in which 40 cases used with Precise Position and another 40 cases without the usage of Precise Position in order to meet the sample size calculation of 40 cases performed average on a CT scanner per day. The thorough clinical evaluation of this feature is done by 5 Clinical experts.

The testing did not deliver radiation to volunteers as Precise Position is only for supporting the positioning of the patient for the localization radiograph and therefore “radiation” was not required for those volunteers.

Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd. Section 5 - 510(k) Summary Precise Position Page 5 of 6

Traditional 510(k)

The clinical evaluation was done with 3 major objectives as follows, To calculate the time saved per surview planning with and without Precise Position.

To calculate the accuracy of vertical (iso)center positioning and Surview (horizontal) start /end position with and without Precise Position Intra operator consistency in positioning the patient and surview scan range

The summary of clinical evaluation testing was clearly demonstrating the objectives in terms of user benefits as shown below Average Time taken to position without Precise Position and with Precise Position is recorded. Time at user select the patient from Gantry Panel, to time when user pressed Go button from Gantry Panel is measured and concluded that up to 23% time reduction in patient positioning achieved with “Precise Positioning workflow”.

The average offset in mm for vertical (iso) center position among 5 operators without Precise Position and with Precise Position is recorded and results shown that with “Precise Position” the vertical position accuracy is increased up to 50%.

Standard deviation in mm for vertical (iso)center positioning & Surview (horizontal) start position among 5 operators without Precise Position and with Precise Position is recorded and results shown up to 70% increase in Vertical and horizontal position consistency with Precise Position.

Overall, the Precise Position Clinical Review Report. (Appendix_007) concluded that Philips Incisive CT systems with Precise Position, under normal condition of use, perform as intended, are safe for its intended use and have a favorable benefit-risk ratio. Further clinical investigations are not necessary, as sufficient evidence exists to support these conclusions. Substantial The Precise Position is substantially equivalent to the primary Equivalence currently marketed and predicate device (K180015, 20/March/2018) in Conclusion: terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. Additionally, substantial equivalence was demonstrated with non-clinical performance tests, which complied with the requirements specified in the international and FDA-recognized consensus standards, IEC 62304 and ISO 14971. The results of these tests demonstrate that Precise Position met the acceptance criteria and is adequate for this intended use.

Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd. Section 5 - 510(k) Summary Precise Position Page 6 of 6